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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04451070
Other study ID # FWH20200114E
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 26, 2020
Est. completion date June 4, 2021

Study information

Verified date June 2021
Source David Grant U.S. Air Force Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to determine if the implementation of a Family Medicine residency curriculum that is based upon the principles of Clinic First, as originally described by the Center for Excellence in Primary Care at the University of California, San Francisco, results in a decrease in the extent of burnout among Family Medicine resident physicians at David Grant Medical Center on Travis Air Force Base in Fairfield, California. This is a descriptive study designed to assess the extent of burnout among Family Medicine resident physicians pre- and post-implementation of a Clinic First-inspired Family Medicine residency curriculum. The study will utilize the Maslach Burnout Inventory Human Services Survey for Medical Personnel (MBI-HSS (MP)), which is a validated instrument that was designed to assess (1) emotional exhaustion, (2) depersonalization, and (3) personal accomplishment among medical personnel.


Description:

This is a descriptive study designed to assess the extent of burnout among Family Medicine resident physicians pre- and post-implementation of a Clinic First-inspired Family Medicine residency curriculum. The study will utilize the Maslach Burnout Inventory Human Services Survey for Medical Personnel (MBI-HSS (MP)). The MBI-HSS (MP) is a validated instrument that was designed to assess (1) emotional exhaustion, (2) depersonalization, and (3) personal accomplishment among medical personnel. The survey will be administered anonymously as a series of 3 surveys both prior to and following the implementation of a Clinic-First inspired curriculum. Survey Period #1: Baseline - within 3 months prior to Clinic First implementation Survey Period #2: Short Term - 3-6 months after Clinic First implementation Survey Period #3: Intermediate Term - 9-12 months after Clinic First implementation The MBI-HSS (MP) will be administered anonymously using printed paper copies to all eligible Family Medicine resident physicians who are in attendance at a Family Medicine residency didactics session within the respective survey period. An independent support staff member from the Clinical Investigations Facility (CIF) will introduce the research study to the resident physicians in attendance using a uniform script and administer the surveys. All Family Medicine resident physicians who meet the eligibility criteria and who are in attendance on the designated didactics day will be provided with a paper copy of the MBI-HSS (MP) and given ample time to complete the questionnaire. The eligible respondents will also be given a separate demographic questionnaire that was generated by the researchers and collects information on gender, age, ethnicity, and marital status. The completed surveys and demographic questionnaires will be collected by the CIF support staff member and de-identified using a using a 4 digit numerical code generated from randomizer.org. The code will be used to link future surveys that are answered by the same resident physician. For those resident physicians who are not in attendance at the designated didactics session, paper copies of the survey and demographic questionnaire will be placed in their personal mailboxes. An email (email address provided by investigators) will be sent to those resident physicians from a member of the CIF support staff informing them that they have 2 weeks to complete the survey and demographic questionnaire and instructing them to place completed surveys/questionnaires in a labeled manila envelope next to the personal mailboxes. The CIF support staff member will pick-up the labeled manila envelope at the end of the 2 week period and de-identify the surveys as described above. This process will be repeated for each survey period such that each eligible resident physician will complete 3 surveys. The MBI-HSS (MP) will be administered as similarly as possible for all participants both pre- and post-curricular transformation to avoid confounding factors. Responses to survey questions will be entered into an Excel spreadsheet by the CIF support staff to be readied for the statistician. Responses will be given numerical data values for analysis. Since all of the questions in the MBI-HSS (MP) have already been assigned numerical value, the responses will be coded accordingly. Descriptive statistics (e.g. frequencies and percentages) will be used to for analysis. For each participant, the level of burnout for each sub-section will be calculated using the MBI scoring results/interpretation, and will be compared across the three time points (ie, baseline, 3-6 months following implementation, and 9-12 months after implementation). Demographic information will be collected to describe the sample. The investigators acknowledge that there may be missing data if resident physicians decline to complete the MBI-HSS (MP), decline to answer all of the questions within the MBI-HSS (MP), or fail to answer subsequent surveys after completing the baseline MBI-HSS (MP). A response rate for each question within each survey period will be calculated and reported. Incomplete surveys will still be reviewed and included in the final data. All analyses will be performed using STATA v.13.0 (College Station, TX).


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date June 4, 2021
Est. primary completion date June 4, 2021
Accepts healthy volunteers
Gender All
Age group 25 Years to 64 Years
Eligibility Inclusion Criteria: - Family Medicine resident physicians at David Grant Medical Center - Residents must have started their Family Medicine residency at David Grant Medical Center between June 2018 - June 2019 - Residents must be scheduled to graduate from Family Medicine residency between June 2021 - June 2022 Exclusion Criteria: - Family Medicine resident physicians at David Grant Medical Center who started their residency before June 2018 or after June 2019. - Family Medicine resident physicians at David Grant Medical Center who are scheduled to graduate from Family Medicine residency before May 2021 or after July 2022.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Clinic First curriculum
The Clinic First model was designed by the Association of Family Medicine Residency Directors (AFMRD) in collaboration with the University of California San Francisco's (UCSF) Center for Excellence in Primary Care. The components of the Clinic First model are summarized in the Association of American Medical Colleges' (AAMC) publication titled "High-Functioning Primary Care Residency Clinics: Building Blocks for Providing Excellent Care and Training". Using the principles of Clinic First, the authors of this study drafted a Family Medicine residency curriculum to be implemented at David Grant Medical Center at the beginning of the 2020-2021 academic year.

Locations

Country Name City State
United States David Grant Medical Center Fairfield California

Sponsors (1)

Lead Sponsor Collaborator
David Grant U.S. Air Force Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (10)

1. Accreditation Council for Graduate Medical Education. "The ACGME Releases 'CLER National Report of Findings 2019: Initial Visits to Sponsoring Institutions With 2 or Fewer Core Residency Programs'." PR Newswire: Press Release Distribution, Targeting, Monitoring and Marketing, Accreditation Council for Graduate Medical Education, 22 Aug. 2019, www.prnewswire.com/newsreleases/the-acgme-releases-cler-national-report-of-findings-2019-initial-visits-to-sponsoringinstitutions-with-2-or-fewer-core-residency-programs-300905975.html.

2. Wagner, Robin. David Grant Medical Center Clinical Learning Environment Review (CLER) Site Visit Report. Accreditation Council for Graduate Medical Education, 2019, pp. 1-21, David Grant Medical Center Clinical Learning Environment Review (CLER) Site Visit Report.

3. "ACGME Program Requirements for Graduate Medical Education in Family Medicine." Accreditation Council for Graduate Medical Education , 1 July 2019, www.msm.edu/Education/GME/Documents/FamilyMedicine/ACGME_Requirements_120_family_medicine_2016.pdf.

4. Bodenheimer, Thomas, et al. High-Functioning Primary Care Residency Clinics: Building Blocks for Providing Excellent Care and Training. Association of American Medical Colleges, 2016, pp. 1-62, High-Functioning Primary Care Residency Clinics: Building Blocks for Providing Excellent Care and Training.

5. "Clinic First Collaborative." Association of Family Medicine Residency Directors (AFMRD), 2020, www.afmrd.org/page/afmrdmembership.

7. "Burn-out an 'Occupational Phenomenon': International Classification of Diseases." World Health Organization, World Health Organization, 28 May 2019, www.who.int/mental_health/evidence/burn-out/en/.

9. Shapiro, Miriam, and Alice Fornari. Factors Influencing Primary Care Residency Selection among Students at an Urban Private Medical School. 1st ed., vol. 25, The Einstein Journal of Biology and Medicine, 2010, pp. 19-24, Factors Influencing Primary Care Residency Selection among Students at an Urban Private Medical School.

Alavi M, Ho T, Stisher C, Richardson E, Kelly C, McCrory K, Snellings J, Zurek K, Boltz MW. Factors That Influence Student Choice in Family Medicine A National Focus Group. Fam Med. 2019 Feb;51(2):143-148. doi: 10.22454/FamMed.2019.927833. — View Citation

Dupras DM, West CP. Training for Careers in Primary Care: Time for Attention to Culture. J Gen Intern Med. 2015 Sep;30(9):1243-4. doi: 10.1007/s11606-015-3416-1. — View Citation

Wallace JE, Lemaire JB, Ghali WA. Physician wellness: a missing quality indicator. Lancet. 2009 Nov 14;374(9702):1714-21. doi: 10.1016/S0140-6736(09)61424-0. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Family Medicine resident physician burnout, baseline Family Medicine resident physician burnout as measured by the Maslach Burnout Inventory Human Services Survey for Medical Personnel (MBI-HSS-MP). Participants will rate how often they experience each of the 22 symptom questions on a scale of 0 (never) to 6 (every day). Both a total score and an average score for each of the 3 subscales (ie, emotional exhaustion, depersonalization, and personal accomplishments) will be calculated. Baseline (before new curriculum was implemented)
Primary Family Medicine resident physician burnout, 3-6 months Family Medicine resident physician burnout as measured by the Maslach Burnout Inventory Human Services Survey for Medical Personnel (MBI-HSS-MP). Participants will rate how often they experience each of the 22 symptom questions on a scale of 0 (never) to 6 (every day). Both a total score and an average score for each of the 3 subscales (ie, emotional exhaustion, depersonalization, and personal accomplishments) will be calculated. 3-6 months after new curriculum was implemented
Primary Family Medicine resident physician burnout, 9-12 months Family Medicine resident physician burnout as measured by the Maslach Burnout Inventory Human Services Survey for Medical Personnel (MBI-HSS-MP). Participants will rate how often they experience each of the 22 symptom questions on a scale of 0 (never) to 6 (every day). Both a total score and an average score for each of the 3 subscales (ie, emotional exhaustion, depersonalization, and personal accomplishments) will be calculated. 9-12 months after new curriculum was implemented